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New Scrutiny for Medical Devices

New York Times, NOVEMBER 18, 2013

Wayne Schneider’s heart stopped beating late last year while the Minneapolis paramedic was out on an emergency call. Another medic performed CPR for a few minutes, and then used a medical device that delivered cardiac compressions mechanically for 64 minutes, until Mr. Schneider’s heart started beating normally on its own.

“I’m not sure people would have been able to sustain manual CPR for so long,” said Mr. Schneider, 57. “I’m a lucky guy.”

He may have been luckier than he knows. Though widely available, the machine used to keep him alive, called an external cardiac compressor, was never subjected to the rigorous premarket approval process that the Food and Drug Administration routinely requires for new drugs.

Now some researchers fear this medical device and nearly a dozen others may never be thoroughly evaluated by the agency.

The reason? These products have been around in one form or another since before the F.D.A. started regulating devices in 1976. They were cleared for sale without close scrutiny because they were presumed to be roughly equivalent to products that already were in use. They also were designated by the F.D.A. as high-risk devices, meaning they sustain human life, are instrumental in preventing harm, or pose an unreasonable risk to patients.

In recent years, Congress has directed the agency to put such high-risk devices through rigorous testing or to change their classification. To the consternation of several consumer watchdog and patient safety groups, the F.D.A. has proposed changing the classification of many of the products so they are no longer considered high-risk, or to vary their classifications depending on their use. Either way, they could still be sold without going through premarket approval.

Among high-risk devices to be “downgraded” are external pacemakers, access tubes implanted in blood vessels, a component of a lung device used for newborns, dental devices that are implanted near the brain, and screw systems used in spinal surgery. At least 10 devices, including defibrillators, metal-on-metal replacement hips, implanted pacemakers and female condoms, will remain high-risk and must undergo premarket approval.

In a statement to The Times, F.D.A. officials said that “every medical device comes with a certain level of risk, whether it is a pair of crutches or a heart valve.” Devices no longer designated as high-risk are still reviewed, the statement said, and “in situations where additional information is needed, the agency may request additional data from the company to ensure that reasonably safe and effective devices are coming to market.”

The external cardiac compressor may have saved Mr. Schneider’s life, but others have not been so fortunate. One of the largest clinical trials of mechanical CPR had to be stopped when safety monitors noticed that patients receiving CPR from external cardiac compressors were much more likely to experience brain damage than those who received manual CPR. The 2006 trial used a different device from the one used on Mr. Schneider, and some critics have questioned its methodology and design.

Despite the mixed data, the F.D.A. plans to take the external cardiac compressor off the high-risk list and reclassify it.

The controversy over high-risk devices is the latest chapter in a long debate over how medical devices are brought to the market. In 2011, an Institute of Medicine report called the F.D.A.’s system for regulating medical devices “flawed,” saying it failed to adequately examine the safety and effectiveness of devices before they were sold. The institute urged the agency to develop a new approach.

In a 2011 study, Dr. Zuckerman and colleagues found that the vast majority of medical devices recalled from 2005 to 2009 because of life-threatening risks had gone on the market without the rigorous premarket approval process. Some were considered equivalent to earlier products, but were designed differently or made of different materials. And some of the earlier devices were themselves problematic.

But although the F.D.A. may never require proof that these devices are safe and effective, the market may. Two companies that make external cardiac compressors have sponsored expensive, time-consuming clinical trials to prove that their devices, which sell for up to $15,000 apiece, are as safe as manual CPR.

Jonathan A. Rennert, president of ZOLL Medical Corporation, which makes AutoPulse cardiac compressors, said a trial sponsored by the company found similar survival rates, and no difference in neurological status, between manual and mechanical CPR. The results have been presented publicly but not yet published in peer-reviewed medical journals.

“That was not a trial we were required to do by the agency,” he said. “It was a trial we felt we needed to do to drive clinical acceptance of the product in the marketplace.”